Polarx FIT Short and Long Tip Cryoablation Balloon Catheter
Issued October 15, 2024
Issue
Boston Scientific is initiating an advisory to provide updates to the POLARx™ and POLARx™ FIT Cryoablation Catheter Instructions For Use (IFUs) related to the risk of atrio-esophageal fistula (AEF). Recall Start Date: October 10, 2024
Hazard description
Labelling and packaging
Product
Product name
Polarx FIT Short and Long Tip Cryoablation Balloon Catheter
Reference
ID
RA-76335
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